MRP/DCP Post Marketing Surveillance Scheme

Background

The end of 2000 saw the creation of a new testing scheme focusing on post-marketing surveillance of Mutual Recognition Procedure (MRP) products, which includes generic medicines. This scheme was initiated on a voluntary basis by members of the General European OMCL Network from EU/EEA Member States and the EDQM, the Network's secretariat. The participants are known as the testing group.

After a 4-year trial period, it was decided, in May 2005, to continue with an annual work programme. Since, this scheme has regularly been followed by approximately 20 OMCLs from 12-15 member states. It is based on the principles of work-sharing and sharing of test results. Both are possible because the MRP enables marketing authorisation (MA) of a medicinal product in more than one EU/EEA Member State.

To guarantee communication among participating OMCLs, the EDQM has installed an IT share point. By avoiding duplicate testing of the same product in different member states, the scheme provides a coordinated and cost savings approach to post-marketing surveillance. Currently, about 700 medicinal products are tested for quality per year within this programme.

Post-Marketing Surveillance of Decentralised Procedure (DCP) Products

A new challenge for the testing group was the implementation of a new community marketing authorisation procedure, the decentralised procedure (DCP), in force since October 2005. This was the end of the transition period for the ratification of the relevant European Parliament and Council Directives (i.e. Directive 2001/83/EC relating to medicinal products for human use as amended by 2004/27/EC and Directive 2001/82/EC relating to veterinary medicinal products as amended by Directive 2004/28/EC).

The decentralised procedure provides equivalent grounds for testing in all member states, as the MA of a DCP product (similar to an MRP product) is based on the same dossier. During the annual meeting of the General European OMCL Network in May 2007, it was decided to include post-marketing surveillance of DCP products within the group's scope.

Achievements in 2018

MRP/DCP Product Testing Scheme

The 14th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out in 2018. Around 1350 product testing projects were allocated to this programme, which is comparable to 2017. This underlines the high acceptance of this programme by the Network members. The test reports came from 29 different OMCLs.

The generic medicines tested in 2018 most frequently contained the following active pharmaceutical ingredients (APIs): quetiapine (antipsychotic), olmesartan (treatment of high blood pressure), amlodipine (treatment of high blood pressure and angina pectoris), pregabalin (antiepileptic), hydrochlorothiazide (treatment of high blood pressure), donepezil (treatment of Alzheimer), candesartan (treatment of high blood pressure), sertraline (antidepressant), aripiprazole (antipsychotic) and zolmitriptan (migraine treatment). Around 5% of samples tested in the programme originated from a member state or an OMCL that was not involved in the testing. This demonstrates the added value of the surveillance scheme with respect to work-sharing and the efforts of the OMCLs to include samples from other member states in their national testing programmes.

For around 2% of the tested materials, findings regarding regulatory issues were identified (e.g. insufficient test method details, labelling issues), and in 2.5% of cases one or more out-of-specification results were reported. Some 11% of the tested products were intended for veterinary use. Since 2012, more DCP- than MRP-products have been included in the annual programmes.

The corresponding internal database, meanwhile, holds around 10.600 MRP- and DCP-producttesting records with contributions from 36 OMCLs. When the total numbers of tested products marketed in participating member states are compared to the numbers of products reported to have been tested between 2002 and 2018 in each participating member state, it has been calculated that there is an average 10-fold gain for EU/EEA countries. This means that by testing one product an average participating member state benefits from the scheme by receiving the testing results for ten marketed products generated by other member states.

Beyond 2018 the task remains to achieve over time, if possible, a balance between the number of samples sent by an OMCL to another Network member for testing and the number of samples from other participants of the programme accepted by the same OMCL for testing. Meanwhile strong features of the CAP generics and MRP/DCP testing schemes are combined on a regular basis to further optimise the testing coverage of generics on the European market. In addition, in 2018 discussions started to make MRP- and DCP-product-related risk assessment data available via the MRP/DCP product testing database of the Network for better planning of market surveillance activities in the OMCLs.

At the end of 2018, compliance with ISO 9001 for the EDQM co-ordination activities with respect to the MRP/DCP product market surveillance scheme was recertified by AFNOR.